Dataset Information

Sutureless Perceval Aortic Valve Versus Conventional Stented Bioprostheses: Meta-Analysis of Postoperative and Midterm Results in Isolated Aortic Valve Replacement.

ABSTRACT:

Background

Aortic stenosis is the most common valvular disease and has a dismal prognosis without surgical treatment. The aim of this meta-analysis was to quantitatively assess the comparative effectiveness of the Perceval (LivaNova) valve versus conventional aortic bioprostheses.

Methods and results

A total of 6 comparative studies were identified, including 639 and 760 patients who underwent, respectively, aortic valve replacement with the Perceval sutureless valve (P group) and with a conventional bioprosthesis (C group). Aortic cross-clamping and cardiopulmonary bypass duration were significantly lower in the P group. No difference in postoperative mortality was shown for the P and C groups (2.8% versus 2.7%, respectively; odds ratio [OR]: 0.99 [95% confidence interval (CI), 0.52-1.88]; P=0.98). Incidence of postoperative renal failure was lower in the P group compared with the C group (2.7% versus 5.5%; OR: 0.45 [95% CI, 0.25-0.80]; P=0.007). Incidence of stroke (2.3% versus 1.7%; OR: 1.34 [95% CI, 0.56-3.21]; P=0.51) and paravalvular leak (3.1% versus 1.6%; OR: 2.52 [95% CI, 0.60-1.06]; P=0.21) was similar, whereas P group patients received fewer blood transfusions than C group patients (1.16±1.2 versus 2.13±2.2; mean difference: 0.99 [95% CI, -1.22 to -0.75]; P=0.001). The incidence of pacemaker implantation was higher in the P than the C group (7.9% versus 3.1%; OR: 2.45 [95% CI, 1.44-4.17]; P=0.001), whereas hemodynamic Perceval performance was better (transvalvular gradient 23.42±1.73 versus 22.8±1.86; mean difference: 0.90 [95% CI, 0.62-1.18]; P=0.001), even during follow-up (10.98±5.7 versus 13.06±6.2; mean difference: -2.08 [95% CI, -3.96 to -0.21]; P=0.030). We found no difference in 1-year mortality.

Conclusions

The Perceval bioprosthesis improves the postoperative course compared with conventional bioprostheses and is an option for high-risk patients.

SUBMITTER: Meco M

PROVIDER: S-EPMC5850177 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Sutureless Perceval Aortic Valve Versus Conventional Stented Bioprostheses: Meta-Analysis of Postoperative and Midterm Results in Isolated Aortic Valve Replacement.

Meco Massimo M Montisci Andrea A Miceli Antonio A Panisi Paolo P Donatelli Francesco F Cirri Silvia S Ferrarini Matteo M Lio Antonio A Glauber Mattia M

Journal of the American Heart Association 20180216 4

<h4>Background</h4>Aortic stenosis is the most common valvular disease and has a dismal prognosis without surgical treatment. The aim of this meta-analysis was to quantitatively assess the comparative effectiveness of the Perceval (LivaNova) valve versus conventional aortic bioprostheses.<h4>Methods and results</h4>A total of 6 comparative studies were identified, including 639 and 760 patients who underwent, respectively, aortic valve replacement with the Perceval sutureless valve (P group) and ...[more]

PMID: 29453309

Similar Datasets

Project description:ObjectiveSutureless aortic valves are an effective option for aortic valve replacement (AVR) showing non-inferiority to standard stented aortic valves for major cardiovascular and cerebral events at 1-year. We report the 1-year hemodynamic performance of the sutureless prostheses compared with standard aortic valves, assessed by a dedicated echocardiographic core lab.MethodsPerceval Sutureless Implant vs. Standard Aortic Valve Replacement (PERSIST-AVR) is a prospective, randomized, adaptive, open-label trial. Patients undergoing AVR, as an isolated or combined procedure, were randomized to receive a sutureless [sutureless aortic valve replacement (Su-AVR)] (n = 407) or a stented sutured [surgical AVR (SAVR)] (n = 412) bioprostheses. Site-reported echocardiographic examinations were collected at 1 year. In addition, a subgroup of the trial population (Su-AVR n = 71, SAVR = 82) had a complete echocardiographic examination independently assessed by a Core Lab (MedStar Health Research Institute, Washington D.C., USA) for the evaluation of the hemodynamic performance.ResultsThe site-reported hemodynamic data of stented valves and sutureless valves are stable and comparable during follow-up, showing stable reduction of mean and peak pressure gradients through one-year follow-up (mean: 12.1 ± 6.2 vs. 11.5 ± 4.6 mmHg; peak: 21.3 ± 11.4 vs. 22.0 ± 8.9 mmHg). These results at 1-year are confirmed in the subgroup by the core-lab assessed echocardiogram with an average mean and peak gradient of 12.8 ± 5.7 and 21.5 ± 9.1 mmHg for Su-AVR, and 13.4 ± 7.7 and 23.0 ± 13.0 mmHg for SAVR. The valve effective orifice area was 1.3 ± 0.4 and 1.4 ± 0.4 cm2 at 1-year for Su-AVR and SAVR. These improvements are observed across all valve sizes. At 1-year evaluation, 91.3% (n = 42) of patients in Su-AVR and 82.3% in SAVR (n = 51) groups were free from paravalvular leak (PVL). The rate of mild PVL was 4.3% (n = 2) in Su-AVR and 12.9% (n = 8) in the SAVR group. A similar trend is observed for central leak occurrence in both core-lab assessed echo groups.ConclusionAt 1-year of follow-up of a PERSIST-AVR patient sub-group, the study showed comparable hemodynamic performance in the sutureless and the stented-valve groups, confirmed by independent echo core lab. Perceval sutureless prosthesis provides optimal sealing at the annulus with equivalent PVL and central regurgitation extent rates compared to sutured valves. Sutureless valves are therefore a reliable and essential technology within the modern therapeutic possibilities to treat aortic valve disease.

Dataset Information

Sutureless Perceval Aortic Valve Versus Conventional Stented Bioprostheses: Meta-Analysis of Postoperative and Midterm Results in Isolated Aortic Valve Replacement.

Background

Methods and results

Conclusions

Publications

Sutureless Perceval Aortic Valve Versus Conventional Stented Bioprostheses: Meta-Analysis of Postoperative and Midterm Results in Isolated Aortic Valve Replacement.

Similar Datasets

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